1. Field of the Invention
This invention relates to methods of, and apparatus for, surgery of the cornea, and more particularly to a laser-based method and apparatus for corneal surgery.
2. Related Art
The concept of correcting refractive errors by changing the curvature of the eye was brought forth early on, as illustrated in the notable mechanical methods pioneered by J. Barraquer. These mechanical procedures involve removal of a thin layer of tissue from the cornea by a micro-keratome, freezing the tissue at the temperature of liquid nitrogen, and re-shaping the tissue in a specially designed lathe. The thin layer of tissue is then re-attached to the eye by suture. One drawback of these methods is the lack of reproducibility and hence a poor predictability of surgical results.
With the advent of lasers, various methods for the correction of refractive errors have been attempted, making use of the coherent radiation properties of lasers, and the precision of the laser-tissue interaction. A CO2 laser was one of the first to be applied in this field. Peyman, et al., in Ophthalmic Surgery, vol. 11, pp. 325–9, 1980, reported laser burns of various intensity, location, and pattern were produced on rabbit corneas. Recently, Horn, et al., in the Journal of Cataract Refractive Surgery, vol. 16, pp. 611–6, 1990, reported that a curvature change in rabbit corneas had been achieved with a Co:MgF2, laser by applying specific treatment patterns and laser parameters. The ability to produce burns on the cornea by either a CO2 laser or a Co:MgF2 laser relies on the absorption in the tissue of the thermal energy emitted by the laser. Histologic studies of the tissue adjacent to burn sites caused by a CO2 laser reveal extensive damage characterized by a denaturalized zone of 5–10 microns deep and disorganized tissue region extending over 50 microns deep. Such lasers are thus ill-suited to corneal laser surgery.
In U.S. Pat. No. 4,784,135, Blum et al. discloses use of far-ultraviolet radiation of wavelengths less than 200 nm to selectively remove biological materials. The removal process is claimed to be by photoetching without requiring heat as the etching mechanism. Medical and dental applications for the removal of damaged or unhealthy tissue from bone, removal of skin lesions, and the treatment of decayed teeth are cited. No specific use for cornea surgery is suggested, and the indicated etch depth of 150 microns is too great for most corneal surgery purposes. Further, even though it is suggested in this reference that the minimum energy threshold for ablation of tissue is 10 mJ/cm2, clinical studies have indicated that the minimum ablation threshold or excimer lasers at 193 nm for cornea tissue is about 50 mJ/cm2.
In U.S. Pat. No. 4,718,418, L'Esperance, Jr. discloses the use of a scanning laser characterized by ultraviolet radiation to achieve controlled ablative photodecomposition of one or more selected regions of a cornea. According to the disclosure, the laser beam from an excimer laser is reduced in its cross-sectional area, through a combination of optical elements, to a 0.5 mm by 0.5 mm rounded-square beam spot that is scanned over a target by deflectable mirrors. (L'Esperance has further disclosed in European Patent Application No. 151869 that the means of controlling the beam location are through a device with a magnetic field to diffract the light beam. It is not clear however, how the wave front of the surgical beam can be affected by an applied magnetic to any practical extent as to achieve beam scanning.) To ablate a corneal tissue surface with such an arrangement, each laser pulse would etch out a square patch of tissue. Each such square patch must be placed precisely right next to the next patch; otherwise, any slight displacement of any of the etched squares would result in grooves or pits in the tissue at the locations where the squares overlap and cause excessive erosion, and ridges or bumps of unetched tissue at the locations in the tissue where the squares where not contiguous. The resulting minimum surface roughness therefore will be about two times the etch depth per pulse. A larger etch depth of 14 microns per pulse is taught for the illustrated embodiment. This larger etch depth would be expected to result in an increase of the surface roughness.
Because of these limitations of laser corneal surgery systems, it is not surprising that current commercial manufactures of excimer laser surgical systems have adopted a different approach to corneal surgery. In U.S. Pat. No. 4,732,148, L'Esperance, Jr. discloses a method of ablating cornea tissue with an excimer laser beam by changing the size of the area on the cornea exposed by the beam using a series of masks inserted in the beam path. The emitted laser beam cross-sectional area remains unchanged and the beam is stationary. The irradiated flux and the exposure time determines the amount of tissue removed.
A problem with this approach is that surface roughness will result from any local imperfection in the intensity distribution across the entire laser beam cross-section.
Furthermore, the intended curvature correction of the cornea will deviate with the fluctuation of the laser beam energy from pulse to pulse throughout the entire surgical procedure. This approach is also limited to inducing symmetric changes in the curvature of the cornea, due to the radially symmetrical nature of the masks. For asymmetric refractive errors, such as those commonly resulting from cornea transplants, one set of specially designed masks would have to be made for each circumstance.
Variations of the above technique of cornea ablation have also been developed for excimer lasers. In U.S. Pat. No. 4,941,093, Marshall et al. discloses the use of a motorized iris in a laser beam path to control the beam exposure area on the cornea. In U.S. Pat. No. 4,856,513, Muller discloses that re-profiling of a cornea surface can be achieved with an erodible mask, which provides a predefined profile of resistance to erosion by laser radiation. This method assumes a fixed etch rate for the tissue to be ablated and for the material of the erodible mask. However, etch characteristics vary significantly, depending on the type of the materials and the local laser energy density. The requirements of uniformity of laser intensity across the beam profile and pulse to pulse intensity stability, as well as limitation of the technique to correct symmetric errors, also apply to the erodible mask method.
Another technique for tissue ablation of the cornea is disclosed in U.S. Pat. No. 4,907,586 to Bille et al. By focusing a laser beam into a small volume of about 25–30 microns in diameter, the peak beam intensity at the laser focal point could reach about 1012 watts per cm2. At such a peak power level, tissue molecules are “pulled” apart under the strong electric field of the laser light, which causes dielectric breakdown of the material. The conditions of dielectric breakdown and its applications in ophthalmic surgery had been described in the book “YAG Laser Ophthalmic Microsurgery” by Trokel. Transmissive wavelengths near 1.06 microns and the frequency-doubled laser wavelength near 530 nm are typically used for the described method. The typical laser medium for such system can be either YAG (yttrium aluminum garnet) or YLF (yttrium lithium fluoride). Bille et al. further discloses that the preferred method of removing tissue is to move the focused point of the surgical beam across the tissue. While this approach could be useful in making tracks of vaporized tissue, the method is not optimal for cornea surface ablation. Near the threshold of the dielectric breakdown, the laser beam energy absorption characteristics of the tissue changes from highly transparent to strongly absorbent. The reaction is very violent, and the effects are widely variable. The amount of tissue removed is a highly non-linear function of the incident beam power. Hence, the tissue removal rate is difficult to control. Additionally, accidental exposure of the endothelium by the laser beam is a constant concern. Most importantly, with the variation in the ablated cross-sectional area and the etch depth, sweeping the laser beam across the cornea surface will most likely result in groove and ridge formation rather than an optically smooth ablated area.
Other problems that occur with some of the prior art systems result from the use of toxic gases as the lasing material. This is particularly a problem with excimer lasers, which are frequently used in health clinic and hospital environments.
An important issue that is largely overlooked in all the above-cited references is the fact that the cornea is a living organism. Like most other organisms, corneal tissue reacts to trauma, whether it is inflicted by a knife or a laser beam. Clinical results have showed that a certain degree of haziness develops in most corneas after laser refractive surgery with the systems taught in the prior art. The principal cause of such haziness is believed to be surface roughness resulting from grooves and ridges formed while laser etching. Additionally, clinical studies have indicated that the extent of the haze also depends in part on the depth of the tissue damage, which is characterized by an outer denatured layer beneath which is a more extended region of disorganized tissue fibers. Another drawback due to a rough corneal surface is related to the healing process after the surgery: clinical studies have confirmed that the degree of haze developed in the cornea correlates with the roughness at the stromal surface.
For reliable ablation results, a current commercial excimer laser corneal surgery system operates at about 150–200 mJ/cm2. The etch depth at 193 nm is about 0.5 microns per pulse, and the damage layer is about 0.3 microns deep. Light scattering from such a surface is expected.
It is therefore desirable to have a method and apparatus for performing corneal surgery that overcomes the limitations of the prior art. In particular, it is desirable to provide an improved method of cornea surgery which has accurate control of tissue removal, flexibility of ablating tissue at any desired location with predetermined ablation depth, an optically smooth, finished surface after the surgery, and a gentler surgical beam for laser ablation action.
The present invention provides such a method and apparatus. The invention resolves the shortcomings of the current corneal surgical systems, including the use of toxic gases, limitations stemming from correcting only symmetric errors in the case of excimer laser systems, the extensive damage caused by Co:MgF2 and CO2 laser systems, and the uncertainty of the etch depth in the case of YAG or YLF laser systems.
Art Related to the Scanner-Amplifier Laser
The control of laser beam positioning has become a key element in many fields of applications, such as image processing, graphic display, materials processing, and surgical applications involving precision tissue removal.
A general overview of the topic is given in “A Survey of Laser Beam Deflection Techniques”, by Fowler and Schlafer, Proceedings of IEEE, vol. 54, no. 10, pages 1437–1444, 1966.
U.S. Pat. No. 3,432,771 to Hardy et al. issued Mar. 11, 1969, disclosed an apparatus for changing the direction of a light beam in an optical cavity. The cavity consists of a focusing objective located between two reflectors, such as curved mirrors. The relative position of one center of curvature with respect to the other center of curvature can be controlled by positioning of one of the mirrors. Points on the reflectors are located at the object and the image positions for the objective. When the active medium is suitably excited, the orientation of the lasing mode, and hence the position of the spots of light, is determined by the effective angular positions of the reflectors.
U.S. Pat. No. 3,480,875 to Pole, issued Nov. 25, 1969, disclosed a laser cavity which was set up between a pair of plane mirrors. At least one active laser element is located between the mirrors. A pair of lens systems are positioned between the mirrors so that they have a common focal plane between them. A Kerr cell, polarizers, and a compensator suppress light oscillation along certain reflector paths within the cavity, thereby setting up preferred modes of oscillation along other paths. Laser emission occurs along the preferred paths.
U.S. Pat. No. 3,597,695 to James E. Swain, issued Aug. 3, 1971, disclosed an apparatus for amplifying laser light by multiple passes through a lasing material in a single laser cavity. A single amplifier stage achieved what had been accomplished by several stages. This is accomplished by a switching mechanism which directs a laser beam into and out of the cavity at selected time intervals, thereby enabling amplification of low intensity laser pulses to an energy level near the damage limits of the optical components of the system.
U.S. Pat. No. 4,191,928 to John L. Emmett, issued Mar. 4, 1980, disclosed a high energy laser system using a regenerative amplifier which relaxes all constraints on laser components other than the intrinsic damage level of matter, so as to enable use of available laser system components. This can be accomplished by use of a segmented component spatial filter.
Many techniques have been developed for controlling the laser beam direction. For the purpose of this invention, this discussion will be limited to the speed, accuracy, and the scan angle range of different devices used in a random access mode.
Galvanometer mirror scanners have a large scan angle range. However, the mechanical response due to the balance of the coil and the applied magnetic field is limited to a few hundred hertz. The settling time and oscillation about the equilibrium point further limits the accuracy attainable with such devices.
Mirrors positionable with piezo actuators are capable of an accurate hunt-free movement response of up to tens of kilohertz, depending on the design of the mounts. The typical scan angle is on the order of a few milli-radians. Methods to enhance the scan angle have been proposed by J. Schlafer and V. J. Fowler, “A Precision, High Speed, Optical Beam Scanner”, Proceedings, International Electron Devices Meeting, 1965. In their report, multiple scanning piezo-mirrors were used to intercept a laser beam, such that the scan angle of each scanner contributes to the total effect, which is the sum of all scan angles. This device requires many individual scanner units, which multiplies in economic cost with the number of units. The mirror size also limits the number of units that can be used before the beam will miss the last mirror.
Furthermore, both of the above methods are applicable in one-dimensional scanning only. For two-dimensional scans, an additional unit, which is either an identical or a mix with another device, must be provided for scanning in the other dimension, doubling cost and space requirements.
In U.S. Pat. No. 3,480,875 to R. V. Pole, disclosed is a scanning laser device, in which the spatial orientation of the laser beam in the resonant cavity is controlled by passing through a combination of a retardation plate and a Kerr cell inside the laser cavity. At a specific angle, as determined by the Kerr cell, loss is minimum for the laser beam, and therefore the laser beam will oscillate in that preferred direction. While this method allows scanning of large angles, the scan speed is limited by the laser build-up time, for which the laser beam intensity will be re-established at each new beam direction. Another drawback of this arrangement is the variation in the laser intensity during the laser build-up.
In U.S. Pat. No. 3,432,771 to W. A. Hardy, disclosed is another scanning laser, in which the optical cavity consists of a focusing objective, and spherical reflectors, or equivalent optics which consist of a lens and a plane mirror. The scan angle is magnified most effectively in an optical arrangement in which the two end reflectors form a nearly concentric cavity with the focusing lens at the center of focus. The drawback is that the cavity tolerates diverging beams to build up inside the cavity, as illustrated in FIG. 1 of the patent, hence the laser output has a high content of multiple transverse modes. By increasing the radius of curvature of the scan mirror and keeping its location fixed, the multi-mode content can be reduced, but the scan range will approach that of the actual scan angle with a possible small magnification factor. As suggested by its preferred embodiment with an electro-optical beam deflector, the scan angle will be only a few milli-radians if a near diffraction limited laser beam is to be produced.
It would thus be desirable to have a scanner amplifier unit which accepts a low energy laser pulse and emits an amplified laser pulse at a predetermined angular positions in two dimensions.